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Claims for Patent: 8,889,099

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Claims for Patent: 8,889,099

Title:Methods and compositions for delivering peptides
Abstract: Methods are provided for purifying peptides and proteins by incorporating the peptide or protein into a diketopiperazine or competitive complexing agent to facilitate removal one or more impurities, from the peptide or protein. Formulations and methods also are provided for the improved transport of active agents across biological membranes, resulting for example in a rapid increase in blood agent concentration. The formulations include microparticles formed of (i) the active agent, which may be charged or neutral, and (ii) a transport enhancer that masks the charge of the agent and/or that forms hydrogen bonds with the target biological membrane in order to facilitate transport. In one embodiment, insulin is administered via the pulmonary delivery of microparticles comprising fumaryl diketopiperazine and insulin in its biologically active form. This method of delivering insulin results in a rapid increase in blood insulin concentration that is comparable to the increase resulting from intravenous delivery.
Inventor(s): Steiner; Solomon S. (Mount Kisco, NY), Woods; Rodney J. (New Hampton, NY), Sulner; Joseph W. (Paramus, NJ)
Assignee: MannKind Corporation (Valencia, CA)
Application Number:13/754,698
Patent Claims: 1. A method of delivering insulin to a human comprising administering a composition comprising insulin bound to a complexing agent to said human by pulmonary inhalation, wherein the composition delivers insulin to the patient in biologically active form after inhalation, wherein said composition produces a rapid onset of insulin action wherein (a) peak blood insulin levels (Tmax.sub.[INS]) are achieved about 13 minutes after inhalation, or (b) peak biological action, measurable as glucose infusion rate (Tmax.sub.GIR) is achieved about 39 minutes after inhalation.

2. The method of claim 1 wherein (Tmax.sub.[INS]) is achieved about 13 minutes after inhalation.

3. The method of claim 1 wherein peak biological action, measurable as (Tmax.sub.GIR), is achieved about 39 minutes after inhalation.

4. The method of claim 1 wherein the complexing agent is a diketopiperazine derivative.

5. The method of claim 4 wherein the diketopiperazine derivative has the formula 2,5-diketo-3,6-di(4-X-aminobutyl)piperazine, wherein X is selected from the group consisting of fumaryl, succinyl, maleyl, and glutaryl.

6. The method of claim 5 wherein the diketopiperazine derivative is 2,5-diketo-3,6-di(4-fumaryl-aminobutyl)piperazine.

7. The method of claim 1 wherein the composition is provided as a dry powder.

8. A composition comprising insulin bound to a complexing agent wherein the composition is-prepared by a method comprising: formulating a composition for pulmonary inhalation; wherein the composition delivers insulin to the patient in biologically active form after inhalation, wherein said composition produces a rapid onset of insulin action when administered to a human wherein (a) peak blood insulin levels (Tmax.sub.[INS]) are achieved about 13 minutes after inhalation, or (b) peak biological action, measurable as glucose infusion rate (Tmax.sub.GIR), is achieved about 39 minutes after inhalation.

9. The composition of claim 8 wherein (Tmax.sub.[INS]) is achieved about 13 minutes after inhalation.

10. The composition of claim 8 wherein peak biological action, measurable as (Tmax.sub.GIR), is achieved about 39 minutes after inhalation.

11. The composition of claim 8 wherein the complexing agent is a diketopiperazine derivative.

12. The composition of claim 11 wherein the diketopiperazine derivative has the formula 2,5-diketo-3,6-di(4-X-aminobutyl)piperazine, wherein X is selected from the group consisting of fumaryl, succinyl, maleyl, and glutaryl.

13. The composition of claim 12 wherein the diketopiperazine derivative is 2,5-diketo-3,6-di(4-fumaryl-aminobutyl)piperazine.

14. The composition of claim 8 wherein the composition is provided as a dry powder.
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